What will happen at the end of the study?
The results will be published in health or scientific journals and be discussed at major conferences. Others will learn from the results, which we hope will show that more lives can be saved by using inclisiran. No individual participant will be identified in any report or publication. We will try our best to inform participants and their GPs of the study results, and any related publicity.
The results will be available on the study website and a description of this clinical trial will be available on the EU Clinical Trials register (EudraCT) and ClinicalTrials.gov.
After the end of the study, inclisiran will not be provided by the ORION-4 team. Currently inclisiran is an investigational drug which means it is not approved for use in the UK other than as part of a research study. However, if the results of ORION-4 show that inclisiran helps to protect against heart attacks and strokes then we hope that it will become widely available for patients.
Participant contribution to the study could be even more valuable if we can continue to get information about health after the final Follow-up visit. This way we can learn a lot more about the possible longer-term health effects of this new treatment.
With permission, the study team may like to stay in touch with participants after the final Follow-up visit, probably with a simple questionnaire or phone call once or twice a year. Also, the study scientists would like to continue to get information about participants' health, such as details of any admissions to hospital from NHS Digital or other central registries after the end of the scheduled study follow-up period. This may include any health information recorded throughout the participants lifetime. Participants can opt out of this at any time by contacting the study team.